高效液相色谱法测定吡非尼酮及其胶囊的含量及有关物质

HPLC determination of content and related substances of pirfenidone and its capsules

目的:应用反相液相色谱法测定吡非尼酮原料及胶囊的含量和有关物质。方法:使用 Diamonsil(钻石)C_(18)(250 mm×4.6 mm,5 μm),流动相为0.05%三乙胺溶液(冰醋酸调 pH 为6.5)-甲醇(1:1),流速1 mL·min^(-1);检测波长:225 nm。结果:吡非尼酮浓度在6～600 μg·mL^(-1)范围内,与峰面积呈良好的线性关系(r=1.000),低、中、高浓度的回收率(n=3)分别为99.7%,100.8%,100.0%;RSD 分别为0.47%,1.5%,0.75%。最低测限为1.12 ng。结论:本法简便、专属,重现性好,可用于测定吡非尼酮含量和有关物质。

Objective：To establish an HPLC method to determine the content and the related substances of pirfeni- done and its capsules. Methods： Diamonsil Cls （250 mm ×4.6 mm,5μm）was used. The flow rate was 1 mL ·min-1. The mobile phase was 0.05% TEA（adjusted to pH 6. 5 with glacial acetic acid） - methanol（ 1：1 ）and the detection wavelength was 225 nm. Results： The linear range of determination was 6 - 600 μg· mL- 1 （ r = 1. 000 ） with the average recoveries （n = 3） of 99. 7% , 100. 8% and 100.0% , RSD 0.47% , 1.5% and 0. 75% ,respective- ly and the lowest detection limit of 1.12 ng. Conclusion ：The methed is simple, specific, and suitable for the determination of pirfenidone and its related substances.